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Quality-Control Analytical Methods: Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 3: A Simplified Endotoxin Test Method for Compounded Sterile Preparations

Author(s):  Cooper James F

Issue:  Jan/Feb 2011 - Volume 15, Number 1
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Abstract:  The first two parts of the IJPC series on endotoxin testing explained the nature of pyrogenic contamination and described various Limulus amebocyte lysate methods for detecting and measuring endotoxin levels with the bacterial endotoxin test described in the United States Pharmacopeia. This third article in that series describes the endotoxin test that is simplest to perform for pharmacists who prefer to conduct an endotoxin assay at the time of compounding in the pharmacy setting.

Related Keywords: James F. Cooper, PharmD, FAPHA, sterile compounding, endotoxin testing, pyrogens, quality assurance, United States Pharmacopeia Chapter <797>, Limulus amebocyte lysate, bacterial endotoxin test, standards, intrathecal administration, intraspinal infusion, intravenous administration, intramuscular administration, patient-controlled analgesia, endotoxin limits, erectile dysfunction injectables, carboxymethylcellulose, injectable suspensions, standard operating procedure

Related Categories: PARENTERALS, STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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